COVID-19NCT05753241
the Relationship Between Allergic Rhinitis and the Risk of Symptom in Patients With Mild COVID-19
An observational study of COVID-19 and Allergic Rhinitis, run by qinxiu zhang at 1 site in China.
Trial summary
At present, most studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection to evaluate the symptoms of AR patients during infection and to provide preventive treatment in advance. So this experiment was designed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Allergic Rhinitis
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 22 Jun 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study period will include all patients attending the ENT outpatient clinic (AR and NO-AR) from December 1, 2022 to December 1, 2023
Who may be able to join
- all participants completed at least one antigen or nucleic acid test and the results were positive.
- the diagnoses of AR met the international diagnostic standards for AR. The participants had obvious clinical symptoms and the allergen test was positive.
Who cannot join
- suspected new infected person with symptoms（ no antigen or nucleic acid test and the results were nagetive ）
- Participants requiring ICU admission after COVID-19 infection-
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, 615100
About this study
Official title: Hospital of Chengdu University of Traditional Chinese Medicine
At present, most studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection to evaluate the symptoms of AR patients during infection and to provide preventive treatment in advance. So this experiment was designed.
Read the detailed description
After the end of this large-scale infection, the investigators analyzed the re-diagnosis of patients with allergic rhinitis (AR) at the Otolaryngology Clinic, and found significant differences in symptoms between AR and non-AR patients. AR patients had more serious nasal and pharyngeal symptoms. In previous studies on the correlation between allergic diseases and COVID-19 infection, AR was found to be a protective factor to reduce COVID-19 infection and the risk of severe disease . In contrast, a cohort study in South Korea found that AR worsened COVID-19 infection . These studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection.
Allergy may lead to the overall damage of nasal mucosa due to the mechanical and immune defense function of the virus. Immunotherapy will significantly reduce the number and severity of upper respiratory tract infections (including children's common cold). The investigators hypothesized that AR is more likely to aggravate symptoms after infection, while allergen immunotherapy （AIT） may reduce the risk of symptoms as a protective factor for symptoms after AR virus infection. Therefore, the investigators conducted a retrospective analysis on the risk of symptoms after COVID-19 infection in patients with AR, and compared the difference of symptoms after COVID-19 infection in patients with AIT and non-AIT AR.
- Conditions
- COVID-19, Allergic Rhinitis
- Being tested
- no intervention
- Keywords
- allergic rhinit, sublingual immunotherapy, the symptoms after COVID-19 infection, Odds ratio
- Medical subject headings
- COVID-19, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
It's only observational study. No interventions.
| Study group | Role | What they receive |
|---|---|---|
| healthy group (HG) | Participants were grouped according to their basic conditions without any intervention Receives: Other: no intervention | |
| allergen immunotherapy group (AIT) | Participants were grouped according to their basic conditions without any intervention Receives: Other: no intervention | |
| allergic rhinitis group (ARG) | Participants were grouped according to their basic conditions without any intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-infection symptoms（pharyngeal symptoms；Systemic symptoms； Gastrointestinal symptoms；Olfactory and gustatory dysfunction；Severe symptoms）
pharyngeal symptoms: dry throat, itchy throat, sore throat, cough, expectoration; Systemic symptoms: fever, headache, fatigue, cold limbs; Gastrointestinal symptoms: diarrhea, constipation; Olfactory and gustatory dysfunction: hypoosmia, hypogustia; Severe symptoms: chest tightness, pant, palpitation, convulsion, coma.
Measured: The first day after COVID-19 infection
hospitalization rate
The probability of needing hospital treatment after infection
Measured: The first day after COVID-19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start10 Nov 2022
- Primary completion20 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- qinxiu zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, qinxiu zhang, Chengdu University of Traditional Chinese Medicine
- Investigators
- qinxiu zhang, Dr., Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753241
- Sponsor's protocol ID
- CDUTCM20230301
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang S, Liu C, Liu Q, He X, Fu Q, Chen X, Jin X, Chen Z, Yang X, Zhang Q, Li X. The relationship between sublingual immunotherapy for allergic rhinitis and the risk of symptoms in patients with COVID-19 infection. Hum Vaccin Immunother. 2023 Aug 1;19(2):2236538. doi: 10.1080/21645515.2023.2236538.
PubMed 37530139
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital of Chengdu University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT05753241
- Acronym / sponsor ID
- CDUTCM20230301
- Conditions
- COVID-19, Allergic Rhinitis
- Keywords
- allergic rhinit, sublingual immunotherapy, the symptoms after COVID-19 infection, Odds ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- qinxiu zhangUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, most studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection to evaluate the symptoms of AR patients during infection and to provide preventive treatment in advance. So this experiment was designed.
Detailed description
After the end of this large-scale infection, the investigators analyzed the re-diagnosis of patients with allergic rhinitis (AR) at the Otolaryngology Clinic, and found significant differences in symptoms between AR and non-AR patients. AR patients had more serious nasal and pharyngeal symptoms. In previous studies on the correlation between allergic diseases and COVID-19 infection, AR was found to be a protective factor to reduce COVID-19 infection and the risk of severe disease . In contrast, a cohort study in South Korea found that AR worsened COVID-19 infection . These studies mainly focussed on severe patients, and there was no comparison of symptom differences between AR patients and healthy people with mild infection.
Allergy may lead to the overall damage of nasal mucosa due to the mechanical and immune defense function of the virus. Immunotherapy will significantly reduce the number and severity of upper respiratory tract infections (including children's common cold). The investigators hypothesized that AR is more likely to aggravate symptoms after infection, while allergen immunotherapy （AIT） may reduce the risk of symptoms as a protective factor for symptoms after AR virus infection. Therefore, the investigators conducted a retrospective analysis on the risk of symptoms after COVID-19 infection in patients with AR, and compared the difference of symptoms after COVID-19 infection in patients with AIT and non-AIT AR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy group (HG) | – | Other: no interventionParticipants were grouped according to their basic conditions without any intervention |
| allergen immunotherapy group (AIT) | – | Other: no interventionParticipants were grouped according to their basic conditions without any intervention |
| allergic rhinitis group (ARG) | – | Other: no interventionParticipants were grouped according to their basic conditions without any intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study period will include all patients attending the ENT outpatient clinic (AR and NO-AR) from December 1, 2022 to December 1, 2023
Key inclusion criteria (2 listed)
- all participants completed at least one antigen or nucleic acid test and the results were positive.
- the diagnoses of AR met the international diagnostic standards for AR. The participants had obvious clinical symptoms and the allergen test was positive.
Key exclusion criteria (2 listed)
- suspected new infected person with symptoms（ no antigen or nucleic acid test and the results were nagetive ）
- Participants requiring ICU admission after COVID-19 infection-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionIt's only observational study. No interventions. | Other | allergen immunotherapy group (AIT), allergic rhinitis group (ARG), healthy group (HG) |
Primary outcome
post-infection symptoms（pharyngeal symptoms；Systemic symptoms； Gastrointestinal symptoms；Olfactory and gustatory dysfunction；Severe symptoms）
Time frame: The first day after COVID-19 infection
pharyngeal symptoms: dry throat, itchy throat, sore throat, cough, expectoration; Systemic symptoms: fever, headache, fatigue, cold limbs; Gastrointestinal symptoms: diarrhea, constipation; Olfactory and gustatory dysfunction: hypoosmia, hypogustia; Severe symptoms: chest tightness, pant, palpitation, convulsion, coma.
hospitalization rate
Time frame: The first day after COVID-19 infection
The probability of needing hospital treatment after infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Results publication: PubMed 37530139Zhang S, Liu C, Liu Q, He X, Fu Q, Chen X, Jin X, Chen Z, Yang X, Zhang Q, Li X. The relationship between sublingual immunotherapy for allergic rhinitis and the risk of symptoms in patients with COVID-19 infection. Hum Vaccin Immunother. 2023 Aug 1;19(2):2236538. doi: 10.1080/21645515.2023.2236538.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
qinxiu zhang, Dr. principal investigator
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Allergic Rhinitis, run by qinxiu zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-infection symptoms（pharyngeal symptoms；Systemic symptoms； Gastrointestinal symptoms；Olfactory and gustatory dysfunction；Severe symptoms） (time frame: The first day after COVID-19 infection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.